FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
- Recall number
- Z-2082-2008
- Recalling firm
- Smith & Nephew Inc
- Product
- TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
- Status
- Terminated
- Initiated
- 2008-04-22
- Posted
- 2008-09-16
- Terminated
- 2010-05-28
- Reason
- One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.
- Root cause
- Process control
- Action
- All affected Smith & Nephew Sales Representatives were notified of problem and the recall via certified letter and e-mail on 4-22-08. All affected Smith & Nephew International Distributors were notified via email on 4-22-08 and 4-23-08. They were instructed to immediately notify their accounts concerning the recall. If you have questions, contact Customer Service at 800-238-7538.
- Quantity
- 8
- Distribution
- Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom.
- Lot, serial or model codes
- Lot No. 07FM16322, exp. 06/2017
- 510(k) numbers
- ["K043052"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28